Anatomical brace for dynamically stabilizing the patella during knee articulation so as to address patella tracking error

ABSTRACT

An anatomical brace for dynamically stabilizing the patella during knee articulation so as to address patella tracking error, the anatomical brace being configured such that, when the anatomical brace is mounted to the knee of a patient, and when the knee thereafter moves to full extension, the anatomical brace applies a proximal/medial force to the patella of the patient, and when the knee thereafter moves to full flexion, the proximal/medial force is released.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This patent application claims benefit of pending prior U.S. ProvisionalPatent Application Ser. No. 62/127,919, filed Mar. 4, 2015 by Andrew M.Blecher, M.D. for ANATOMICAL BRACE FOR DYNAMICALLY STABILIZING THEPATELLA DURING KNEE ARTICULATION SO AS TO ADDRESS PATELLA TRACKING ERROR(Attorney's Docket No. BLECHER-1 PROV), which patent application ishereby incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to anatomical braces in general, and moreparticularly to anatomical braces for dynamically stabilizing thepatella during knee articulation so as to address patella trackingerror.

BACKGROUND OF THE INVENTION

The knee joint is formed at the convergence of the femur and the tibia.The patella (also known as the knee cap) sits on the anterior side ofthe knee joint, at the base of the femur. The patella and the femurtogether form another joint, i.e., the patello-femoral joint. At thepatello-femoral joint, the posterior side of the patella (formed as aridge) engages the anterior side of the femur (formed as a groove). Witha properly functioning patello-femoral joint, the patella ridge rides inthe femoral groove as the knee articulates. Among other things, with aproperly functioning patello-femoral joint, the patella moves fromdistal (in flexion) to proximal (in extension).

Many people suffer from improper tracking of the patella relative to thefemur. More particularly, many people suffer from “patella trackingerror” where the patella fails to track properly along the femur as theknee articulates. In many cases, with patella tracking error, thepatella improperly tracks laterally as the knee moves from flexion toextension, and/or the patella fails to track proximally as the kneemoves from flexion to extension. Less severe forms of patella trackingerror can cause pain in the joint. More severe forms of patella trackingerror can lead to cartilage damage and arthritis of the knee.

As a result, a recognized need exists for effective treatment of patellatracking errors.

In U.S. Pat. No. 6,551,264, issued Apr. 22, 2003 to Cawley et al. forORTHOSIS FOR DYNAMICALLY STABILIZING THE PATELLO-FEMORAL JOINT, there isdisclosed an anatomical brace for dynamically stabilizing the patelladuring knee articulation so as to address patella tracking errors.

While the anatomical brace disclosed in U.S. Pat. No. 6,551,264 is asignificant improvement over prior art anatomical braces, it nonethelesssuffers from a significant design limitation, i.e., it can impose onlylateral-to-medial forces on the patella as the knee moves from flexionto extension, and is unable to impose distal-to-proximal forces (ordiagonal forces) on the patella as the knee moves from flexion toextension. As a result, the anatomical brace disclosed in U.S. Pat. No.6,551,264 is only partially successful in dynamically stabilizing thepatella during knee articulation so as to address patella trackingerrors.

In addition, the anatomical brace disclosed in U.S. Pat. No. 6,551,264also suffers from several additional design limitations.

Among other things, the anatomical brace disclosed in U.S. Pat. No.6,551,264 tends to be relatively heavy and intrusive, inasmuch as ituses a so-called “double hinge construction” in which hinge mechanismsare disposed on both the lateral and medial sides of the knee joint, andincludes a substantial body of fabric on the posterior side of the kneewhich impedes full flexion of the knee (e.g., due to bunching in theback of the brace).

Furthermore, the anatomical brace disclosed in U.S. Pat. No. 6,551,264can migrate during use, inasmuch as it uses only a single strap tosecure the anatomical brace to the calf of the patient and uses only asingle strap to secure the anatomical brace to the thigh of the patient.

And it should also be appreciated that the anatomical brace disclosed inU.S. Pat. No. 6,551,264 suffers from the fact that it does notadequately relax the forces applied around the kneecap during kneeflexion, and hence the anatomical brace disclosed in U.S. Pat. No.6,551,264 is “too tight” around the kneecap during knee flexion.

As a result, one object of the present invention is to provide a novelanatomical brace for dynamically stabilizing the patella during kneearticulation so as to address patella tracking errors, wherein theanatomical brace is configured to apply distal-to-proximal, as well aslateral-to-medial, forces (i.e., as distal-to-proximal/lateral-to-medialdiagonal forces) to the patella as the knee moves from flexion toextension.

And another object of the present invention is to provide a novelanatomical brace which is relatively lightweight and non-intrusive, byeliminating the so-called “double hinge construction”, and by avoidingthe use of a substantial body of fabric on the posterior side of theknee which could impede full flexion of the knee (e.g., due to bunchingin the back of the brace).

And another object of the present invention is to provide a novelanatomical brace which is more resistant to migration during use, byproviding a more robust securement to the calf of the patient and byproviding a more robust securement to the thigh of the patient.

And another object of the present invention is to provide a novelanatomical brace which relaxes the forces applied to the patella duringknee flexion so that the novel anatomical brace is not “too tight”around the kneecap during knee flexion.

SUMMARY OF THE INVENTION

These and other objects are addressed by the present invention, whichcomprises the provision and use of a novel anatomical brace fordynamically stabilizing the patella during knee articulation so as toaddress patella tracking errors.

Among other things, the novel anatomical brace is configured to applydistal-to-proximal, as well as lateral-to-medial, forces (i.e., asdistal-to-proximal/lateral-to-medial diagonal forces) to the patella asthe knee moves from flexion to extension.

And the novel anatomical brace is configured to be relativelylightweight and non-intrusive, by eliminating the so-called “doublehinge construction”, and by avoiding the use of a substantial body offabric on the posterior side of the knee which could impede full flexionof the knee (e.g., due to bunching in the back of the brace).

And the novel anatomical brace is configured to be more resistant tomigration during use, by providing a more robust securement to the calfof the patient and by providing a more robust securement to the thigh ofthe patient.

And the novel anatomical brace is configured to relax the forces appliedto the patella during knee flexion so that the novel anatomical brace isnot “too tight” around the kneecap during knee flexion.

In one preferred form of the invention, there is provided an anatomicalbrace for dynamically stabilizing the patella during knee articulationso as to address patella tracking error, said anatomical bracecomprising:

a brace body comprising:

-   -   a distal band having a first end, a second end and a fastener        for securing together said first end of said distal band and        said second end of said distal band;    -   a proximal band having a first end, a second end and a fastener        for securing together said first end of said proximal band and        said second end of said proximal band;    -   a medial connector having a distal end and a proximal end, said        distal end of said medial connector being connected to said        distal band and said proximal end of said medial connector being        connected to said proximal band;    -   a lateral connector having a distal end and a proximal end, said        distal end of said lateral connector being connected to said        distal band and said proximal end of said lateral connector        being connected to said proximal band;    -   said distal band, said proximal band, said medial connector and        said lateral connector together defining a central opening sized        to receive the patella of a patient;

a hinge mechanism comprising a distal segment, a proximal segment and apivot for pivotally connecting said distal segment and said proximalsegment, said distal segment of said hinge mechanism being connected tosaid distal band and said proximal segment of said hinge mechanism beingconnected to said proximal band;

a first cable guide mounted to the posterior portion of said pivot;

a second cable guide mounted to said proximal segment of said hingemechanism;

a third cable guide secured to said lateral connector;

a cable having a first end and a second end;

said first end of said cable being mounted to said distal segment ofsaid hinge mechanism, said second end of said cable being mounted to atleast one of said distal band and said lateral connector, and said cablebeing routed proximally along said distal segment of said hingemechanism, through said first cable guide, proximally along saidproximal segment of said hinge mechanism, through said second cableguide, laterally along said proximal band, distally along said lateralconnector and through said third cable guide;

wherein, when said anatomical brace is mounted to the knee of a patientso that said distal band is secured to the calf of the patient, saidproximal band is secured to the thigh of the patient and the patella ofthe patient is received in said central opening of said brace body, andwhen the knee thereafter moves to full extension, said cable istensioned, whereby to apply a proximal/medial force to the patella ofthe patient, and when the knee thereafter moves to full flexion, saidcable is relaxed, so that the proximal/medial force is released.

In another preferred form of the invention, there is provided a methodfor dynamically stabilizing the patella during knee articulation so asto address patella tracking error, said method comprising:

providing an anatomical brace comprising:

-   -   a brace body comprising:        -   a distal band having a first end, a second end and a            fastener for securing together said first end of said distal            band and said second end of said distal band;        -   a proximal band having a first end, a second end and a            fastener for securing together said first end of said            proximal band and said second end of said proximal band;        -   a medial connector having a distal end and a proximal end,            said distal end of said medial connector being connected to            said distal band and said proximal end of said medial            connector being connected to said proximal band;        -   a lateral connector having a distal end and a proximal end,            said distal end of said lateral connector being connected to            said distal band and said proximal end of said lateral            connector being connected to said proximal band;        -   said distal band, said proximal band, said medial connector            and said lateral connector together defining a central            opening sized to receive the patella of a patient;    -   a hinge mechanism comprising a distal segment, a proximal        segment and a pivot for pivotally connecting said distal segment        and said proximal segment, said distal segment of said hinge        mechanism being connected to said distal band and said proximal        segment of said hinge mechanism being connected to said proximal        band;    -   a first cable guide mounted to the posterior portion of said        pivot;    -   a second cable guide mounted to said proximal segment of said        hinge mechanism;    -   a third cable guide secured to said lateral connector;    -   a cable having a first end and a second end;    -   said first end of said cable being mounted to said distal        segment of said hinge mechanism, said second end of said cable        being mounted to at least one of said distal band and said        lateral connector, and said cable being routed proximally along        said distal segment of said hinge mechanism, through said first        cable guide, proximally along said proximal segment of said        hinge mechanism, through said second cable guide, laterally        along said proximal band, distally along said lateral connector        and through said third cable guide; and

mounting said anatomical brace to the knee of a patient so that saiddistal band is secured to the calf of the patient, said proximal band issecured to the thigh of the patient and the patella of the patient isreceived in said central opening of said brace body;

such that when the knee thereafter moves to full extension, said cableis tensioned, whereby to apply a proximal/medial force to the patella ofthe patient, and when the knee thereafter moves to full flexion, saidcable is relaxed, so that the proximal/medial force is released.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view showing the novel anatomical brace of thepresent invention from the medial side, with the knee in full flexion;

FIG. 2 is a schematic view showing the novel anatomical brace of thepresent invention from the anterior side, with the knee in full flexion;

FIG. 3 is a schematic view showing the novel anatomical brace of thepresent invention from the lateral side, with the knee in full flexion;

FIG. 4 is a schematic view showing the novel anatomical brace of thepresent invention from the medial side, with the knee in full extension;

FIG. 5 is a schematic view showing the novel anatomical brace of thepresent invention from the anterior side, with the knee in fullextension;

FIG. 6 is a schematic view showing the novel anatomical brace of thepresent invention from the lateral side, with the knee in fullextension;

FIG. 7 is a schematic view showing the front (anterior) side of thenovel anatomical brace of the present invention, with the anatomicalbrace laid out flat on a surface;

FIG. 8 is a schematic view showing the rear (posterior) side of thenovel anatomical brace of the present invention, with the anatomicalbrace laid out flat on a surface;

FIGS. 9-12 are schematic views showing operation of the novel anatomicalbrace as the knee moves from flexion to extension;

FIGS. 13 and 14 are schematic views showing operation of the novelanatomical brace as the knee moves from extension to flexion;

FIG. 15 is a schematic view showing another form of the novel anatomicalbrace of the present invention;

FIG. 16 is a schematic view showing still another form of the novelanatomical brace of the present invention; and

FIG. 17 is a schematic view showing one form of a cover which may bepositioned over the novel anatomical brace during use.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention comprises the provision and use of a novelanatomical brace for dynamically stabilizing the patella during kneearticulation so as to address patella tracking errors.

Among other things, the novel anatomical brace is configured to applydistal-to-proximal, as well as lateral-to-medial, forces (i.e., asdistal-to-proximal/lateral-to-medial diagonal forces) to the patella asthe knee moves from flexion to extension.

And the novel anatomical brace is configured to be relativelylightweight and non-intrusive, by eliminating the so-called “doublehinge construction”, and by avoiding the use of a substantial body offabric on the posterior side of the knee which could impede full flexionof the knee (e.g., due to bunching in the back of the brace).

And the novel anatomical brace is configured to be more resistant tomigration during use, by providing a more robust securement to the calfof the patient and by providing a more robust securement to the thigh ofthe patient.

And the novel anatomical brace is configured to relax the forces appliedto the patella during knee flexion so that the novel anatomical brace isnot “too tight” around the kneecap during knee flexion.

Construction Of The Novel Anatomical Brace

Looking first at FIGS. 1-8 , in one preferred form of the inventionthere is provided a novel anatomical brace 5 for dynamically stabilizingthe patella during knee articulation so as to address patella trackingerrors. Anatomical brace 5 generally comprises a brace body 10comprising a distal band 15 having a first end 20 and a second end 25, aproximal band 30 having a first end 35 and a second end 40, a medialconnector 45 having a distal end 50 and a proximal end 55, and a lateralconnector 60 having a distal end 65 and a proximal end 70. Distal band15, proximal band 30, medial connector 45 and lateral connector 60together define a central opening 72 within brace body 10. Brace body 10is flexible, and is preferably formed out of a flexible sheet materialsuch as a woven fabric, a synthetic rubber, etc. In one preferred formof the invention, brace body 10 is formed out of neoprene or a neopreneblend.

One half 75 of a hook-and-mesh (e.g, Velcro®) fastener is fixed to thefront (anterior) side of first end 20 of distal band 15 and the otherhalf 80 of a hook-and-mesh (e.g, Velcro®) fastener is fixed to the rear(posterior) side of second end 25 of distal band 15, such that distalband 15 can be wrapped about the calf of a patient and secured in place.One half 85 of a hook-and-mesh (e.g., Velcro®) fastener is fixed to thefront (anterior) side of first end 35 of proximal band 30 and the otherhalf 90 of a hook-and-mesh (e.g., Velcro®) fastener is fixed to the rear(posterior) side of second end 40 of proximal band 30, such thatproximal band 30 can be wrapped about the thigh of a patient and securedin place.

A pair of distal straps 95, each having a first end 100 and a second end105, are secured to distal band 15 at their first ends 100. One half 110of a hook-and-mesh (e.g, Velcro®) fastener is fixed to the front(anterior) side of each of first ends 100 of distal straps 95 and theother half 115 of a hook-and-mesh (e.g, Velcro®) fastener is fixed tothe rear (posterior) side of each of second ends 105 of distal straps95, such that distal straps 95 can be wrapped over distal band 15 andsecured in place after distal band 15 has been secured to the calf of apatient.

A proximal strap 120, having a first end 125 and a second end 130, issecured to proximal band 30 at its first end 125. One half 135 of ahook-and-mesh (e.g., Velcro®) fastener is fixed to the front (anterior)side of first end 125 of proximal strap 120 and the other half 140 of ahook-and-mesh (e.g., Velcro®) fastener is fixed to the rear (posterior)side of second end 130 of proximal strap 120, such that proximal strap120 can be wrapped over proximal band 30 and secured in place afterproximal band 30 has been secured to the thigh of a patient.

Central opening 72 of brace body 10 is sized to receive the patella of apatient, as will hereinafter be discussed.

A hinge mechanism 145 is mounted over medial connector 45 and secured todistal band 15 and proximal band 30. More particularly, hinge mechanism145 comprises a distal segment 150 and a proximal segment 155, withdistal segment 150 being connected to proximal segment 155 at a pivot160. Distal segment 150 of hinge mechanism 145 is secured to distal band15 and proximal segment 155 of hinge mechanism 145 is secured toproximal band 30. Distal segment 150 of hinge mechanism 145, andproximal segment 155 of hinge mechanism 145, are each relatively stiff,and are preferably formed out of a lightweight metal, or a plastic, or acarbon fiber, etc. Pivot 160 of hinge mechanism 145 is relativelyfrictionless (i.e., it is easily articulated) and is preferably formedas an assembly comprising a central disc-shaped body to which bothdistal segment 150 and proximal segment 155 are pivotally attached.Alternatively, pivot 160 can comprise a simple “rivet pivot” or “screwpivot” of the sort well known in the art.

A first cable guide (e.g., a pivot guide) 162 is mounted to the portionof pivot 160 which faces posteriorly when anatomical brace 5 is securedto the knee of a patient (for purposes of the present disclosure, firstcable guide 162 is sometimes hereinafter referred to as being mounted to“the posterior portion of pivot 160”, and/or to “the posterior side ofpivot 160”, etc.).

A second cable guide (e.g., a guide pulley) 165 is adjustably mounted toproximal segment 155 of hinge mechanism 145. More particularly, secondcable guide (e.g., guide pulley) 165 is mounted to proximal segment 155of hinge mechanism 145 so that the distance between second cable guide(e.g., guide pulley) 165 and pivot 160 may be adjusted by the user. Inone preferred form of the invention, second cable guide (e.g., guidepulley) 165 is adjustably mounted to proximal segment 155 of hingemechanism 145, e.g., using a screw and a plurality of holes.

A third cable guide (e.g., a brace tunnel) 167 is formed on lateralconnector 60. Where third cable guide 167 comprises a brace tunnel, thebrace tunnel may be formed out of the same material as brace body 10, orthe brace tunnel may be formed out of a different material than bracebody 10.

A cable 170 extends between distal segment 150 of hinge mechanism 145and a distal lateral portion of brace body 10 of anatomical brace 5.More particularly, cable 170 comprises a first end 182 which isadjustably secured to distal segment 150 of hinge 145, and a second end183 which is adjustably secured to a lateral portion of distal band 15,with the intermediate portion of cable 170 extending proximally alongdistal segment 150 of hinge mechanism 150, through first cable guide(e.g., pivot guide) 162, proximally along proximal segment 155 of hingemechanism 150, through second cable guide (e.g., guide pulley) 165,laterally along proximal band 30, distally along lateral connector 60,and then through third cable guide (e.g., brace tunnel) 167.

Note that with this cable pathway, first end 182 of cable 170 passesthrough first cable guide (e.g., pivot guide) 162, which is positionedon the posterior side of pivot 160 so as to keep first end 182 of cable170 toward the posterior side of pivot 160. By virtue of thisconstruction, and as will hereinafter be discussed in further detail,cable 170 is able to release tension when the knee flexes and increasetension when the knee extends. This is a significant improvement in theart. Thus it will be seen that the present invention provides a hingedknee brace (i.e., a patellofemoral knee brace) with a cable system wherethe cable passes along the length of the hinge and posteriorly to thehinge pivot. This unique design allows for tightening of the cable(therefore resulting in the application of pressure to the kneecap)during knee extension and loosening of the cable (therefore resulting inreleasing pressure from the kneecap) during flexion.

And note that with this cable pathway, second end 183 of cable 170passes through third cable guide (e.g., brace tunnel) 167 positioned onlateral connector 60 so as to stabilize second end 183 of cable 170laterally of the patella, and second end 183 of cable 170 is secured toa lateral portion of distal band 15. By virtue of this construction,cable 170 is able to apply lateral-to-medial, and distal-to-proximal,forces (i.e., as distal-to-proximal/lateral-to-medial diagonal forces)to the patella as the knee moves from flexion to extension.

It should be appreciated that first end 182 of cable 170 is adjustablymounted to distal segment 150 of hinge mechanism 145 such that theposition of first end 182 of cable 170 can be adjusted relative todistal segment 150 of hinge mechanism 145, whereby to change the angle,direction and/or tension of cable 170, in order to accommodate thepatient's anatomy. In one preferred form of the invention, first end 182of cable 170 is adjustably mounted to distal segment 150 of hingemechanism 145 using a screw and a plurality of holes.

It should also be appreciated that second end 183 of cable 170 isadjustably mounted to distal band 15 of brace body 10 such that theposition of second end 183 of cable 170 can be adjusted relative todistal band 15 of brace body 10, whereby to change the angle, directionand/or tension of cable 170, in order to accommodate the patient'sanatomy. In one preferred form of the invention, second end 183 of cable170 is adjustably mounted to distal band 15 using a hook-and-mesh (e.g.,Velcro®) fastener. By way of example but not limitation, one half 184 ofa hook-and-mesh (e.g., Velcro®) fastener is fixed to second end 183 ofcable 170 and the other half of a hook-and-mesh (e.g., Velcro®) fasteneris provided by the element 75 previously described.

And it should be appreciated that second cable guide (e.g., guidepulley) 165 is adjustably mounted to proximal segment 155 of hingemechanism 145 such that the position of second cable guide (e.g., guidepulley) 165 on proximal segment 155 of hinge mechanism 145 can beadjusted, whereby to change the angle, direction and/or tension of cable170, in order to accommodate the patient's anatomy.

In one preferred form of the invention, first end 182 of cable 170 isformed out of a relatively inelastic material such as stainless steeland second end 183 of cable 170 is formed out of an elastomeric material(e.g., rubber, a rubber substitute, an elastic weave, etc.). As a resultof this construction, when cable 170 is tensioned, first end 182 ofcable 170 is substantially unstretchable while second end 175 of cable170 can elongate to some (i.e., a limited) extent.

Note that forming second end 183 of cable 170 out of an elastomericmaterial has several significant advantages. First, it is convenient forthe healthcare professional during fitting of anatomical brace 5, sinceit minimizes the need for cable sizing and eliminates concerns aboutexcessive or inadequate cable lengths. Second, it eliminates concernsabout cable bunching when the knee is in flexion (i.e., when the knee isbent), since the elastomeric nature of the cable takes up excess cablelength when tension on the cable is relaxed. Third, the elastomericnature of the cable is able to accommodate the patient's anatomy duringextension (i.e., knee straightening), and eliminates the concern thatthe limit of the cable will be reached before the leg is in fullextension. Of course, it will also be appreciated that while second end183 of cable 170 is preferably elastic to some (i.e., a limited) extent,it is not so elastic as to prevent cable 170 and brace body 10 fromapplying forces to the patella during flexion of the knee. And fourth,during knee extension, the elastomeric nature of second end 183 of thetensioned cable 170 pulls the tibia towards the femur, whereby toprovide (through the patella tendon) distal-to-proximal forces on thepatella (which reduces the load on the patella tendon, thereby makinganatomical brace 5 useful for patients with patella tendonitis).

Use Of The Novel Anatomical Brace

In use, and still looking now at FIGS. 1-8 , anatomical brace 5 is firstsecured to the patient by positioning brace body 10 over the knee sothat central opening 72 of brace body 10 receives the patella of thepatient and makes a relatively close fit about the distal and lateralportions of the patella, placing medial connector 45 over the medialportion of the knee, and placing lateral connector 60 over the lateralportion of the knee; and by fitting distal band 15 about the calf of thepatient and making it fast with hook-and-mesh (e.g, Velcro®) fastener75, 80, and fitting proximal band 30 about the thigh of the patient andmaking it fast with hook-and-mesh (e.g., Velcro®) fastener 85, 90. Thendistal straps 95 are tightened about distal band 15 using hook-and-mesh(e.g., Velcro®) fasteners 110, 115, and proximal strap 120 is tightenedabout proximal band 30 using hook-and-mesh (e.g, Velcro®) fastener 135,140.

Note that by positioning brace body 10 so that central opening 72 ofbrace body 10 receives the patella of the patient, brace body 10 andcable 170 of anatomical brace 5 will surround the patella of thepatient.

Note also that by securing distal straps 95 over distal band 15, a moresecure yet comfortable attachment can be made to the calf of thepatient, and by securing proximal strap 120 over proximal band 30, amore secure yet comfortable attachment can be made to the thigh of thepatient.

Note further that when anatomical brace 5 is positioned in this mannerabout the knee of the patient, hinge mechanism 145 will extend along themedial portion of the knee, and the rear of the knee is leftsubstantially uncovered by anatomical brace 5.

And note also that no hinge mechanism is disposed along the lateralportion of the knee.

Next, cable 170 has its first end 182 adjustably secured to distalsegment 150 of hinge mechanism 145. Then, with the knee close to (butnot at) full extension (i.e., with the knee nearly straightened), cable170 is routed proximally along distal segment 150 of hinge mechanism,through first cable guide (e.g., pivot guide) 162, proximally alongproximal segment 155 of hinge mechanism 150, through second cable guide(e.g., guide pulley) 165, laterally along proximal band 30, distallyalong lateral connector 60, through third cable guide (e.g., bracetunnel) 167 and then down to a distal lateral portion of brace body 10of anatomical brace 5 (e.g. to hook-and-fastener element 75), wheresecond end 183 of cable 170 is adjustably secured in place.

Note that when cable 170 is routed in this manner, the cable passesposterior to pivot 160 and alongside, and substantially engages, thelateral portions of the patella, and terminates distal to the patella.

As a result, when the knee thereafter moves to full extension, cable 170is tensioned, whereby to apply a distal-to-proximal, as well aslateral-to-medial, force (i.e., as distal-to-proximal/lateral-to-medialdiagonal forces) on the patella; and when the knee thereafter moves toflexion, cable 170 is relaxed, so that the forces applied to the patellaby the cable are also relaxed.

More particularly, when the knee moves to full extension, cable 170 istensioned, whereby to pull brace body 10 of anatomical brace 5proximally and medially (i.e., in a proximal/medial diagonal direction).This proximal/medial force is applied to (i) the patella of the patientvia brace body 10 (inasmuch as central opening 72 of brace body 10receives the patella of the patient and makes a relatively close fitabout the distal and lateral portions of the patella), and (ii) thetibia of the patient (inasmuch as distal band 15 or brace body 10 issecured to the upper calf of the patient, and hence the tibia of thepatient, and the second end 183 of cable 170 is anchored to distal band15), which force is in turn transferred to the patella via the patellatendon. See FIGS. 9-12 .

Conversely, when the knee moves to full flexion, cable 170 is relaxed,so that the proximal/medial diagonal force on brace body 10 (and hencethe patella of the patient) is released. See FIGS. 13 and 14 .

Thus it will be seen that, on account of the foregoing construction,when the knee articulates from flexion to extension (see FIGS. 9-12 ),anatomical brace 5 applies distal-to-proximal, as well aslateral-to-medial, forces (i.e., as distal-to-proximal/lateral-to-medialdiagonal forces) on the patella, whereby to correct for patella trackingerrors, and when the knee articulates from extension to flexion (seeFIGS. 13 and 14 ), anatomical brace 5 relaxes the forces applied to thepatella.

This is a significant improvement in the art.

Among other things, the use of a guided cable system that allows theanatomical brace to engage the patella with distal-to-proximal, as wellas lateral-to-medial, forces (i.e., asdistal-to-proximal/lateral-to-medial diagonal forces) during kneeextension, and relax those forces during knee flexion, is a uniquefeature not found in the prior art and which is highly advantageous overthe anatomical braces of the prior art. This is made possible by the useof the unique guided cable system of the present invention, where thecable passes along the length of the hinge mechanism and posteriorly tothe hinge pivot.

Among other things, it should also be noted that by providing cable 170with an elastic second end 183, cable 170 can stretch (to some extent)when the cable is tensioned during knee extension (i.e., during kneestraightening), and cable 170 can contract (to some extent) when thecable is relaxed during knee flexion (i.e., during knee bending).

And it should be noted that, forming second end 183 of cable 170 out ofan elastomeric material (i) provides increased convenience for thehealthcare professional during fitting of anatomical brace 5, since itminimizes the need for cable sizing and eliminates concerns aboutexcessive or inadequate cable lengths; (ii) eliminates concerns aboutcable bunching when the knee is in flexion (i.e., when the knee isbent), since the elastomeric nature of the cable takes up excess cablelength when tension on the cable is relaxed; (iii) accommodates thepatient's anatomy during extension (i.e., knee straightening), andeliminates the concern that the limit of the cable will be reachedbefore the leg is in full extension; (of course, it will also beappreciated that while second end 183 of cable 170 is preferably elasticto some extent, it is not so elastic as to prevent cable 170 and bracebody 10 from applying forces to the patella during flexion of the knee);and (iv) during knee extension, the elastomeric nature of second end 183of the tensioned cable 170 pulls the tibia toward the femur, whereby toprovide (through the patella tendon) distal-to-proximal forces on thepatella (which reduces the load on the patella tendon, thereby makinganatomical brace 5 useful for patients with patella tendonitis).

These features are also significant improvements in the art.

Significantly, anatomical brace 5 is relatively lightweight andnon-intrusive, since it utilizes a single-hinge construction and avoidsa so-called “double hinge construction”, and avoids the use of asubstantial body of fabric on the posterior side of the knee which couldimpede full flexion of the knee (e.g., due to bunching in the back ofthe brace). Thus it will be seen that the present invention provides alight weight and low profile brace that, among other things, preventsbunching in the back of the brace and tightness when the knee is bent.

And anatomical brace 5 is more resistant to migration during use, byproviding a more robust securement to the calf of the patient and byproviding a more robust securement to the thigh of the patient.

And anatomical brace 5 is configured to relax the forces applied to thepatella during knee flexion so that anatomical brace 5 is not “tootight” around the kneecap during knee flexion.

In the foregoing disclosure, it was noted that first end 182 of cable170 is adjustably mounted to distal segment 150 of hinge mechanism 145such that the position of first end 182 of cable 170 can be adjustedrelative to distal segment 150 of hinge mechanism 145, whereby to changethe angle, direction and/or tension of cable 170, in order toaccommodate the patient's anatomy; and it was noted that in onepreferred form of the invention, first end 182 of cable 170 isadjustably mounted to distal segment 150 of hinge mechanism 145 using ascrew and a plurality of holes. However, it will be apparent to thoseskilled in the art that many other mounting mechanisms may be utilizedif desired. By way of example but not limitation, and looking now atFIG. 15 , first end 182 of cable 170 may adjustably mounted to distalsegment 150 of hinge mechanism 145 by providing a rail 200 on distalsegment 150 of hinge mechanism 145, and by mounting first end 182 ofcable 170 to a rider 205 which is slidably mounted to rail 200, with afixation element (e.g., a set screw, not shown) being used to lock rider205 in place at a desired position along rail 200.

And in the foregoing disclosure, it was noted that second cable guide(e.g., guide pulley) 165 is adjustably mounted to proximal segment 155of hinge mechanism 145 such that the position of second cable guide(e.g., guide pulley) 165 can be adjusted relative to proximal segment155 of hinge mechanism 145, whereby to change the angle, directionand/or tension of cable 170, in order to accommodate the patient'sanatomy; and it was noted that in one preferred form of the invention,second cable guide (e.g., guide pulley) 165 is adjustably mounted toproximal segment 155 of hinge mechanism 145 using a screw and aplurality of holes. However, it will be apparent to those skilled in theart that many other mounting mechanisms may be utilized if desired. Byway of example but not limitation, and looking now at FIG. 15 , secondcable guide (e.g., guide pulley) 165 may adjustably mounted to proximalsegment 155 of hinge mechanism 145 by providing a rail 210 on proximalsegment 155 of hinge mechanism 145, and by mounting second cable guide(e.g., guide pulley) 165 to a rider 215 which is slidably mounted torail 210, with a fixation element (e.g., a set screw, not shown) beingused to lock rider 215 in place at a desired position along rail 210.

FIG. 16 shows another form of the novel anatomical brace of the presentinvention. This form of the invention is generally similar to theconstruction shown in FIG. 15 , except that various components of thehinge mechanism are formed with a lighter weight construction.

And in the foregoing disclosure it was noted that second end 183 ofcable 170 is adjustably mounted to distal band 15 of brace body 10 suchthat the position of second end 183 of cable 170 can be adjustedrelative to distal band 15 of brace body 10, whereby to change theangle, direction and/or tension of cable 170, in order to accommodatethe patient's anatomy; and it was noted that in one preferred form ofthe invention, second end 183 of cable 170 is adjustably mounted todistal band 15 of brace body 10 using a hook-and-mesh (e.g. Velcro®)fastener. However, it will be apparent to those skilled in the art thatmany other mounting mechanisms (e.g., snap fasteners, cable clamps,cable tie-downs, etc.) may be used to adjustably mount second end 183 ofcable 170 to distal band 15 of brace body 10.

In the foregoing disclosure, it is noted that first cable guide 162 maybe a pivot guide, second cable guide 165 may be a guide pulley, andthird cable guide 167 may be a brace tunnel; however, it should also beappreciated that other elements (e.g., rings, eyelets, tubes, etc.) maybe used to form first cable guide 162, second cable guide 165 and/orthird cable guide 167 (i.e., essentially any structure capable ofguiding cable 170 in a manner consistent with the present invention).

In addition to the foregoing, it will also be appreciated that it may bedesirable to provide a covering for novel anatomical brace 5 so as toshield the operative elements of the anatomical brace from inadvertentcontact during use, e.g., to shield hinge mechanism 145, cable 170,first cable guide (e.g., guide pulley) 162, second cable guide (e.g.,guide pulley) 165, third cable guide (e.g., brace tunnel) 167, etc. frominadvertent contact during use. To this end, and looking now at FIG. 17, an elastic sleeve 220 may be provided for selectively covering novelanatomical brace 5, with the elastic sleeve 220 being pulled up over theanatomical brace during use. Alternatively, an overlying covering orpanel may be permanently (or temporarily) attached to anatomical brace 5(e.g., to portions of brace body 10), with the covering or panel able tobe laid open (e.g., folded back) when it is necessary to access theoperative elements of the anatomical brace (e.g., to adjust thedisposition of cable 170) and the covering or panel being closable(e.g., laid back over the operative elements and secured in place) whenthe anatomical brace is in use.

MODIFICATIONS

It is to be understood that the present invention is by no means limitedto the particular constructions herein disclosed and/or shown in thedrawings, but also comprises any modifications or equivalents within thescope of the invention.

1. An anatomical brace for dynamically stabilizing the patella duringknee articulation so as to address patella tracking error, saidanatomical brace comprising: a brace body comprising: a distal bandhaving a first end, a second end and a fastener for securing togethersaid first end of said distal band and said second end of said distalband; a proximal band having a first end, a second end and a fastenerfor securing together said first end of said proximal band and saidsecond end of said proximal band; a medial connector having a distal endand a proximal end, said distal end of said medial connector beingconnected to said distal band and said proximal end of said medialconnector being connected to said proximal band; a lateral connectorhaving a distal end and a proximal end, said distal end of said lateralconnector being connected to said distal band and said proximal end ofsaid lateral connector being connected to said proximal band; saiddistal band, said proximal band, said medial connector and said lateralconnector together defining a central opening sized to receive thepatella of a patient; a hinge mechanism comprising a distal segment, aproximal segment and a pivot for pivotally connecting said distalsegment and said proximal segment, said distal segment of said hingemechanism being connected to said distal band and said proximal segmentof said hinge mechanism being connected to said proximal band; a firstcable guide mounted to the posterior portion of said pivot; a secondcable guide mounted to said proximal segment of said hinge mechanism; athird cable guide secured to said lateral connector; a cable having afirst end and a second end; said first end of said cable being mountedto said distal segment of said hinge mechanism, said second end of saidcable being mounted to at least one of said distal band and said lateralconnector, and said cable being routed proximally along said distalsegment of said hinge mechanism, through said first cable guide,proximally along said proximal segment of said hinge mechanism, throughsaid second cable guide, laterally along said proximal band, distallyalong said lateral connector and through said third cable guide;wherein, when said anatomical brace is mounted to the knee of a patientso that said distal band is secured to the calf of the patient, saidproximal band is secured to the thigh of the patient and the patella ofthe patient is received in said central opening of said brace body, andwhen the knee thereafter moves to full extension, said cable istensioned, whereby to apply a proximal/medial force to the patella ofthe patient, and when the knee thereafter moves to full flexion, saidcable is relaxed, so that the proximal/medial force is released.
 2. Ananatomical brace according to claim 1 wherein said brace body comprisesa flexible sheet material.
 3. An anatomical brace according to claim 2wherein said flexible sheet material comprises at least one from thegroup consisting of a woven fabric and a synthetic rubber.
 4. Ananatomical brace according to claim 3 wherein said flexible sheetmaterial comprises neoprene.
 5. An anatomical brace according to claim 1wherein said fastener for securing together said first end of saiddistal band and said second end of said distal band comprises ahook-and-mesh fastener.
 6. An anatomical brace according to claim 1wherein said fastener for securing together said first end of saidproximal band and said second end of said proximal band comprises ahook-and-mesh fastener.
 7. An anatomical brace according to claim 1wherein said anatomical brace is configured so that, when saidanatomical brace is mounted to the knee of a patient, and when the kneeof the patient thereafter moves to full flexion, said anatomical bracedoes not bunch in the back of said anatomical brace and cause tightnessin the back of the knee of the patient.
 8. An anatomical brace accordingto claim 1 wherein said pivot of said hinge mechanism comprises acentral disk-shaped body to which said distal segment of said hingemechanism and said proximal segment of said hinge mechanism arepivotally attached.
 9. An anatomical brace according to claim 1 whereinsaid pivot of said hinge mechanism comprises one from the groupconsisting of a rivet pivot and a screw pivot.
 10. An anatomical braceaccording to claim 1 wherein first cable guide comprises one from thegroup consisting of a pivot guide, a guide pulley, a tunnel, a ring, aneyelet and a tube.
 11. An anatomical brace according to claim 1 whereinsaid second cable guide is adjustably mounted to said proximal segmentof said hinge mechanism.
 12. An anatomical brace according to claim 1wherein said second cable guide comprises one from the group consistingof a pivot guide, a guide pulley, a tunnel, a ring, an eyelet and atube.
 13. An anatomical brace according to claim 1 wherein said thirdcable guide comprises one from the group consisting of a pivot guide, aguide pulley, a tunnel, a ring, an eyelet and a tube.
 14. An anatomicalbrace according to claim 1 wherein said first end of said cable issubstantially inelastic and said second end of said cable is elastic.15. An anatomical brace according to claim 1 wherein said first end ofsaid cable is adjustably mounted to said distal segment of said hingemechanism.
 16. An anatomical brace according to claim 1 wherein saidsecond end of said cable is adjustably mounted to at least one of saiddistal band and said lateral connector.
 17. A method for dynamicallystabilizing the patella during knee articulation so as to addresspatella tracking error, said method comprising: providing an anatomicalbrace comprising: a brace body comprising: a distal band having a firstend, a second end and a fastener for securing together said first end ofsaid distal band and said second end of said distal band; a proximalband having a first end, a second end and a fastener for securingtogether said first end of said proximal band and said second end ofsaid proximal band; a medial connector having a distal end and aproximal end, said distal end of said medial connector being connectedto said distal band and said proximal end of said medial connector beingconnected to said proximal band; a lateral connector having a distal endand a proximal end, said distal end of said lateral connector beingconnected to said distal band and said proximal end of said lateralconnector being connected to said proximal band; said distal band, saidproximal band, said medial connector and said lateral connector togetherdefining a central opening sized to receive the patella of a patient; ahinge mechanism comprising a distal segment, a proximal segment and apivot for pivotally connecting said distal segment and said proximalsegment, said distal segment of said hinge mechanism being connected tosaid distal band and said proximal segment of said hinge mechanism beingconnected to said proximal band; a first cable guide mounted to theposterior portion of said pivot; a second cable guide mounted to saidproximal segment of said hinge mechanism; a third cable guide secured tosaid lateral connector; a cable having a first end and a second end;said first end of said cable being mounted to said distal segment ofsaid hinge mechanism, said second end of said cable being mounted to atleast one of said distal band and said lateral connector, and said cablebeing routed proximally along said distal segment of said hingemechanism, through said first cable guide, proximally along saidproximal segment of said hinge mechanism, through said second cableguide, laterally along said proximal band, distally along said lateralconnector and through said third cable guide; and mounting saidanatomical brace to the knee of a patient so that said distal band issecured to the calf of the patient, said proximal band is secured to thethigh of the patient and the patella of the patient is received in saidcentral opening of said brace body; such that when the knee thereaftermoves to full extension, said cable is tensioned, whereby to apply aproximal/medial force to the patella of the patient, and when the kneethereafter moves to full flexion, said cable is relaxed, so that theproximal/medial force is released. 18.-22. (canceled)
 23. A methodaccording to claim 17 wherein said anatomical brace is configured sothat, when said anatomical brace is mounted to the knee of a patient,and when the knee of the patient thereafter moves to full flexion, saidanatomical brace does not bunch in the back of said anatomical brace andcause tightness in the back of the knee of the patient. 24.-26.(canceled)
 27. A method according to claim 17 wherein said second cableguide is adjustably mounted to said proximal segment of said hingemechanism. 28.-30. (canceled)
 31. A method according to claim 17 whereinsaid first end of said cable is adjustably mounted to said distalsegment of said hinge mechanism, and further wherein said second end ofsaid cable is adjustably mounted to at least one of said distal band andsaid lateral connector.
 32. (canceled)